VALIDation of Bedside Ultrasound of Muscle Layer Thickness of the Quadriceps in the Critically Ill Patient

NCT04676464 | Completed

• 1 other identifier: VALIDUM
• Study Type: observational
• Target: 204
• Locations: 0 countries
• Sites: N/A

Brief Summary

The overall objective is to evaluate the validity of bedside US of QMLT and MF-BIA by comparing measurements from US and MF-BIA to those estimates of lean body mass obtained from CT Scan of abdomen when done for clinical reasons. The investigators expect to observe a high degree of correlation between these 3 baseline measures and the changes in US measures and MF-BIA over time to correlate with changes to CT Scan measures of lean body mass.

Conditions

Critical Illness; Muscle Atrophy

Keywords

computed tomography; muscle atrophy; muscle thickness; intensive care unit; ultrasound

Outcome Measures

Primary Outcomes (1)

• Validity of bedside US of QMLT

  To evaluate the validity and reliability of bedside US by comparing measurements from US and to those estimates of lean body mass obtained from CT Scan of abdomen.

  12 months

Study Arms (1)

ultra- sound

ultra- sound assessment of their quadriceps muscle layer thickness (QMLT)

Diagnostic Test: Ultra- sound

Interventions

Ultra- sound DIAGNOSTIC_TEST

Ultrasound assessment of quadricep muscle layer thickness QMLT within 72hrs of initial CT scan

ultra- sound

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study will enroll a broad heterogeneous patient population who will be admitted to the ICU for inpatient care. We are particularly interested in the cohort of patients with trauma but will enroll non-trauma patients who have CT scans as well to do some between group comparisons.

You may qualify if:

• Abdominal CT scan performed for clinical reasons within 24 hours before or 72 hours after admission

You may not qualify if:

• Patients under age 18 years
• Moribund patient with devastating injuries and not expected to survive
• Patients whose clinical condition precludes performing an ultrasound
• Pregnant women
• Prisoners
• Mentally-disabled individuals

Sponsors & Collaborators

• Clinical Evaluation Research Unit at Kingston General Hospital: lead

MeSH Terms

Conditions

Critical Illness; Muscular Atrophy

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Clinical Evaluation Research Unit

Study Record Dates

• First Submitted: December 15, 2020
• First Posted: December 21, 2020
• Study Start: December 1, 2013
• Primary Completion: January 1, 2014
• Study Completion: March 1, 2015
• Last Updated: December 22, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share